udi compliance software

Overview

Beginning September 24, 2014 and going forward, all medical device manufacturers are required to meet the FDA mandated UDI compliance for their Class I, II and III devices, in phases.

Source – GS1 Healthcare US® | www.gs1us.org/healthcare

The primary concern facing companies is how to navigate across some of the major challenges in the process of meeting the strict FDA timelines.

1. Unidentified DI/ PI Sources & Data Configuration

2. Inaccurate Document Version Control

3. Error-prone Manual Data Submissions

4. Non-existent Data Validation System

5. Incompatible Publishing & Reporting

Effectively handling large volumes of unstructured data from disparate and non-authenticated sources is one of the biggest challenges for manufacturers in meeting their UDI compliance obligations. Add to that the lack of version control measures, cumbersome manual submission, and inadequate data management process making the challenges far greater to handle.

With the timelines getting shorter every day, companies are looking out for a right partner with an effective solution to successfully navigate through the UDI landscape. Freyr IDENTITY leverages the Plan, Process and Training methodology to offer an end-to-end UDI compliance solution.

Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.

UDI compliance software

Freyr IDENTITY ensures reliable regulatory compliance with GxP practice 21 CFR Part 11, including additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to enable accurate, efficient and faster UDI compliance.